Integration of palliative care into standard oncology care: American Society of Clinical Oncology clinical practice guideline update.

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by  National Guideline Clearinghouse (NGC)

General
Guideline Title
Integration of palliative care into standard oncology care: American Society of Clinical Oncology clinical
practice guideline update.
Bibliographic Source(s)
Ferrell BR, Temel JS, Temin S, Alesi ER, Balboni TA, Basch EM, Firn JI, Paice JA, Peppercorn JM, Phillips
T, Stovall EL, Zimmermann C, Smith TJ. Integration of palliative care into standard oncology care:
American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2017
Jan;35(1):96-112. [73 references] PubMed
Guideline Status
This is the current release of the guideline.
This guideline meets NGC's 2013 (revised) inclusion criteria.
Recommendations
Major Recommendations
Definitions for the rating of evidence (High, Intermediate, Low, Insufficient); types of recommendations
(Evidence based, Formal consensus, Informal consensus, No recommendation); and strength of
recommendations (Strong, Moderate, Weak) are provided at the end of the "Major Recommendations"
field.
Clinical Question 1
What is the most effective way to care for patients with advanced cancer symptoms (palliative care
services in addition to usual care compared with usual care alone)?
Recommendation 1: Patients with advanced cancer should be referred to interdisciplinary palliative care
teams (consultation) that provide inpatient and outpatient care early in the course of disease, alongside
active treatment of their cancer (Type: evidence based, benefits outweigh harms; Evidence quality:
intermediate; Strength of recommendation: strong).
Clinical Question 2
What are the most practical models of palliative care? Who should deliver palliative care (external
consultation, internal consultations with palliative care practitioners in the oncology practice, or
performed by the oncologist him- or herself)?
Recommendation 2: Palliative care for patients with advanced cancer should be delivered through
interdisciplinary palliative care teams, with consultation available in both outpatient and inpatient
settings (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of
recommendation: moderate).
Clinical Question 3
How is palliative care in oncology defined or conceptualized?
Recommendation 3: Patients with advanced cancer should receive palliative care services, which may
include a referral to a palliative care provider. Essential components of palliative care include: rapport and
relationship building with patient and family caregivers; symptom, distress, and functional status
management (e.g., pain, dyspnea, fatigue, sleep disturbance, mood, nausea, or constipation);
exploration of understanding and education about illness and prognosis; clarification of treatment goals;
assessment and support of coping needs (e.g., provision of dignity therapy); assistance with medical
decision making; coordination with other care providers; and provision of referrals to other care providers
as indicated. For newly diagnosed patients with advanced cancer, the Expert Panel suggests early
palliative care involvement, starting early in the diagnosis process and ideally within 8 weeks of
diagnosis (Type: informal consensus; Evidence quality: intermediate; Strength of recommendation:
moderate).
Clinical Question 4
How can palliative care services relate in practice to other existing or emerging supportive care services
(including nurse navigation, lay navigation, community and home health care, geriatric oncology, psycho-
oncology, and pain services)?
Recommendation 4: Among patients with cancer with high symptom burden and/or unmet physical or
psychosocial needs, outpatient programs of cancer care should provide and use dedicated resources
(palliative care clinicians) to deliver palliative care services to complement existing program tools (Type:
informal consensus, benefits outweigh harms; Evidence quality: intermediate; Strength of
recommendation: moderate).
Clinical Question 5
Which interventions are helpful for family caregivers?
Recommendation 5: For patients with early or advanced cancer for whom family caregivers will provide
care in outpatient, home, or community settings, nurses, social workers, or other providers may initiate
caregiver-tailored palliative care support, which could include telephone coaching, education, referrals,
and face-to-face meetings. For family caregivers who may live in rural areas and/or are unable to travel to
clinic and/or longer distances, telephone support may be offered (Type: evidence based; Evidence quality:
low; Strength of recommendation: weak).
Clinical Question 6
Which patients should be offered or referred to palliative care services, and when in their disease
trajectory; are there triggers that should be used to prompt specialty palliative care referrals?
Special Commentary: Interventional studies support early specialty palliative care referrals among
patients with advanced-stage malignancies and their caregivers. However, additional triggers should be
considered among all patients with cancer to ensure prompt referrals to specialty palliative care services
for patients at high risk for specialty palliative care needs. Furthermore, oncologists should be educated
in primary palliative care competencies and regularly assess triggers for palliative care specialty services
as part of their care of patients with cancer and their family caregivers. Additional studies are needed to
better define triggers for meeting unmet specialty palliative care needs in the population of patients with
cancer. See the Special Commentary in the original guideline document for a discussion of the evidence
concerning referral to palliative care services.
Definitions
Guide for Rating Quality of Evidence
Rating for Definition
Strength of
Evidence
High High confidence that the available evidence reflects the true magnitude and direction of
the net effect (i.e., balance of benefits versus harms) and that further research is very
unlikely to change either the magnitude or direction of this net effect.
Intermediate Moderate confidence that the available evidence reflects the true magnitude and
direction of the net effect. Further research is unlikely to alter the direction of the net
effect; however, it might alter the magnitude of the net effect.
Low Low confidence that the available evidence reflects the true magnitude and direction of
the net effect. Further research may change either the magnitude and/or direction of
this net effect.
Insufficient Evidence is insufficient to discern the true magnitude and direction of the net effect.
Further research may better inform the topic. The use of the consensus opinion of
experts is reasonable to inform outcomes related to the topic.
Guide for Types of Recommendations
Type of Definition
Recommendation
Evidence based There was sufficient evidence from published studies to inform a recommendation
to guide clinical practice.
Formal consensus The available evidence was deemed insufficient to inform a recommendation to
guide clinical practice. Therefore, the Expert Panel used a formal consensus
process to reach this recommendation, which is considered the best current
guidance for practice. The Expert Panel may choose to provide a rating for the
strength of the recommendation (i.e., "strong," "moderate," or "weak"). The
results of the formal consensus process are summarized in the guideline and
reported in the Data Supplement (see the "Availability of Companion Documents"
field).
Informal The available evidence was deemed insufficient to inform a recommendation to
consensus guide clinical practice. The recommendation is considered the best current
guidance for practice, based on informal consensus of the Expert Panel. The
Expert Panel agreed that a formal consensus process was not necessary for
reasons described in the literature review and discussion. The Expert Panel may
choose to provide a rating for the strength of the recommendation (i.e., "strong,"
"moderate," or "weak").
No There is insufficient evidence, confidence, or agreement to provide a
recommendation recommendation to guide clinical practice at this time. The Expert Panel deemed
the available evidence as insufficient and concluded it was unlikely that a formal
consensus process would achieve the level of agreement needed for a
recommendation.
Guide for Strength of Recommendations
Rating for Definition
Strength of
Recommendation
Strong There is high confidence that the recommendation reflects best practice. This is
based on (1) strong evidence for a true net effect (e.g., benefits exceed harms);
(2) consistent results, with no or minor exceptions; (3) minor or no concerns
about study quality; and/or (4) the extent of Expert Panelists' agreement. Other
compelling considerations (discussed in the guideline's literature review and
analyses) may also warrant a strong recommendation.
Moderate There is moderate confidence that the recommendation reflects best practice. This
Rating for Definition
is based on (1) good evidence for a true net effect (e.g., benefits exceed harms);
Strength of
(2) consistent results, with minor and/or few exceptions; (3) minor and/or few
Recommendation
concerns about study quality; and/or (4) the extent of Expert Panelists'
agreement. Other compelling considerations (discussed in the guideline's
literature review and analyses) may also warrant a moderate recommendation.
Weak There is some confidence that the recommendation offers the best current
guidance for practice. This is based on (1) limited evidence for a true net effect
(e.g., benefits exceed harms); (2) consistent results, but with important
exceptions; (3) concerns about study quality; and/or (4) the extent of Expert
Panelists' agreement. Other considerations (discussed in the guideline's literature
review and analyses) may also warrant a weak recommendation.
Clinical Algorithm(s)
None provided
Scope
Disease/Condition(s)
Advanced cancer
Guideline Category
Management
Treatment
Clinical Specialty
Oncology
Intended Users
Advanced Practice Nurses
Health Care Providers
Hospitals
Nurses
Other
Patients
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Social Workers
Guideline Objective(s)
To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers,
and palliative care specialists to update the 2012 American Society of Clinical Oncology (ASCO)
provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all
patients diagnosed with cancer
Target Population
Patients with advanced cancer and their caregivers
Note: Patients with advanced cancer are deï¬​ned as those with distant metastases, late-stage disease, cancer that is life limiting, and/or
with prognosis of 6 to 24 months.
Interventions and Practices Considered
1. Referral to interdisciplinary palliative care teams (consultation) that provide inpatient and outpatient
care
2. Components of palliative care services
3. Timing of referral to palliative care
4. Use of dedicated resources (palliative care clinicians) to deliver palliative care services to
complement existing program tools
5. Caregiver-tailored palliative care support, such as telephone coaching, education, referrals, and face-
to-face meetings
Major Outcomes Considered
Quality of life (QOL)
Symptom relief
Psychological outcomes
Survival
Satisfaction
Methodology
Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
The recommendations were developed by an Expert Panel with multidisciplinary representation. The
American Society of Clinical Oncology (ASCO) guidelines staff supplemented and updated the literature
search that was conducted to inform its recommendations on palliative care. PubMed was searched from
March 2010 to January 2016. The panel based its recommendations on phase III randomized controlled
trials (RCTs), secondary analyses of RCTs discussed in 2012, and clinical experience. In some selected
cases where evidence was lacking, but there was a high level of agreement among Expert Panel
members, informal consensus was used. Articles were selected for inclusion in the systematic review of
the evidence based on the following criteria: the population discussed in the articles was patients
diagnosed with cancer, and articles were fully published English-language reports of phase III RCTs or
published secondary analyses of RCTs in the 2012 provisional clinical option (PCO), rigorously conducted
systematic reviews, or meta-analyses.
Articles were excluded from the systematic review if they were: meeting abstracts not subsequently
published in peer-reviewed journals; editorials, commentaries, letters, news articles, case reports, or
narrative reviews; or published in a non-English language.
Literature Search Strategy
PubMed and the Cochrane Collaboration Library electronic databases (± meeting abstracts) were searched
for evidence reporting on outcomes of interest.
Details of the literature search strategy are provided in Data Supplements 3 and 4 (see the "Availability
of Companion Documents" field). A Quality of Reporting of Meta-analyses (QUOROM) Diagram illustrating
the article selection process is available in Data Supplement 4.
Number of Source Documents
A total of nine new randomized controlled trials (RCTs), two publications reporting on one large
quasiexperimental trial, and five secondary publications based on prior published RCTs met eligibility
criteria and/or were suggested by the Expert Panel and form the evidentiary basis for the guideline
recommendations.
See the Quality of Reporting of Meta-analyses (QUOROM) Diagram (Data Supplement 4) in the Data
Supplement (see the "Availability of Companion Documents" field) for an outline of the study selection
process.
Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Guide for Rating Quality of Evidence
Rating for Definition
Strength of
Evidence
High High confidence that the available evidence reflects the true magnitude and direction of
the net effect (i.e., balance of benefits versus harms) and that further research is very
unlikely to change either the magnitude or direction of this net effect.
Intermediate Moderate confidence that the available evidence reflects the true magnitude and
direction of the net effect. Further research is unlikely to alter the direction of the net
effect; however, it might alter the magnitude of the net effect.
Low Low confidence that the available evidence reflects the true magnitude and direction of
the net effect. Further research may change either the magnitude and/or direction of
this net effect.
Insufficient Evidence is insufficient to discern the true magnitude and direction of the net effect.
Further research may better inform the topic. The use of the consensus opinion of
experts is reasonable to inform outcomes related to the topic.
Guide for Rating of Potential for Bias
Rating of Definitions for Rating Potential for Risk of Bias in Randomized Controlled Trials
Potential
for Bias
Low risk No major features in the study that risk biased results, and none of the limitations are
thought to decrease the validity of the conclusions. The study avoids problems such as
failure to apply true randomization, selection of a population unrepresentative of the
target patients, high dropout rates, and no intention-to-treat analysis; and key study
features are described clearly (including the population, setting, interventions,
comparison groups, measurement of outcomes, and reasons for dropouts).
Intermediate The study is susceptible to some bias, but flaws are not sufficient to invalidate the
results. Enough of the items introduce some uncertainty about the validity of the
conclusions. The study does not meet all the criteria required for a rating of good
quality, but no flaw is likely to cause major bias. The study may be missing
information, making it difficult to assess limitations and potential problems.
High risk There are significant flaws that imply biases of various types that may invalidate the
results. Several of the items introduce serious uncertainty about the validity of the
conclusions. The study has serious errors in design, analysis, or reporting; large
amounts of missing information; or discrepancies in reporting.
Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Data Extraction
Literature search results were reviewed and deemed appropriate for full text review by one American
Society of Clinical Oncology (ASCO) staff reviewer in consultation with the Expert Panel Co-Chairs. Data
were extracted by one staff reviewer and subsequently checked for accuracy through an audit of the data
by another ASCO staff member. Disagreements were resolved through discussion and consultation with
the Co-Chairs if necessary. Evidence tables are provided in the original guideline document and/or in Data
Supplements 1 and 2 (see the "Availability of Companion Documents" field).
Study Quality Assessment
Study quality was formally assessed for the studies identified. Design aspects related to the individual
study quality were assessed by one reviewer and included factors such as blinding, allocation
concealment, placebo control, intention to treat, funding sources, etc. The risk of bias is assessed as
"low," "intermediate," or "high" for most of the identified evidence.
Methods Used to Formulate the Recommendations
Expert Consensus
Informal Consensus
Description of Methods Used to Formulate the Recommendations
Expert Panel Composition
The American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines Committee (CPGC) convened
an Expert Panel with multidisciplinary representation in palliative care, medical oncology, community
oncology, oncology nursing, radiation oncology, oncology social work, thoracic oncology, and
patient/advocacy representation. The Expert Panel was led by two Co-Chairs who had primary
responsibility for the development and timely completion of the guideline. For this guideline product, the
Co-Chairs selected one additional member to assist in the development and review of the guideline
drafts.
Guideline Development Process
The Expert Panel met on several occasions and corresponded frequently through e-mail; progress on
guideline development was driven primarily by the Co-Chairs/Steering Committee along with ASCO staff.
The purpose of the meetings was for members to contribute content, provide critical review, interpret
evidence, and finalize the guideline recommendations based upon the consideration of the evidence. All
members of the Expert Panel participated in the preparation of the draft guideline document.
Development of Recommendations
The guideline recommendations were crafted, in part, using the GuideLines Into DEcision Support
(GLIDES) methodology and accompanying BRIDGE-Wiz software™. This method helps guideline expert
panels systematically develop clear, translatable, and implementable recommendations using natural
language, based on the evidence and assessment of its quality to increase usability for end users. The
process incorporates distilling the actions involved, identifying who will carry them out, to whom, under
what circumstances, and clarifying if and how end users can carry out the actions consistently. This
process helps the Expert Panel focus the discussion, avoid using unnecessary and/or ambiguous
language, and clearly state its intentions.
Rating Scheme for the Strength of the Recommendations
Guide for Types of Recommendations
Type of Definition
Recommendation
Evidence based There was sufficient evidence from published studies to inform a recommendation
to guide clinical practice.
Formal consensus The available evidence was deemed insufficient to inform a recommendation to
guide clinical practice. Therefore, the Expert Panel used a formal consensus
process to reach this recommendation, which is considered the best current
guidance for practice. The Expert Panel may choose to provide a rating for the
strength of the recommendation (i.e., "strong," "moderate," or "weak"). The
results of the formal consensus process are summarized in the guideline and
reported in the Data Supplement (see the "Availability of Companion Documents"
field).
Informal The available evidence was deemed insufficient to inform a recommendation to
consensus guide clinical practice. The recommendation is considered the best current
guidance for practice, based on informal consensus of the Expert Panel. The
Expert Panel agreed that a formal consensus process was not necessary for
reasons described in the literature review and discussion. The Expert Panel may
choose to provide a rating for the strength of the recommendation (i.e., "strong,"
"moderate," or "weak").
No There is insufficient evidence, confidence, or agreement to provide a
recommendation recommendation to guide clinical practice at this time. The Expert Panel deemed
the available evidence as insufficient and concluded it was unlikely that a formal
consensus process would achieve the level of agreement needed for a
recommendation.
Guide for Strength of Recommendations
Rating for Definition
Strength of
Recommendation
Strong There is high confidence that the recommendation reflects best practice. This is
based on (1) strong evidence for a true net effect (e.g., benefits exceed harms);
(2) consistent results, with no or minor exceptions; (3) minor or no concerns
about study quality; and/or (4) the extent of Expert Panelists' agreement. Other
Rating for Definition
compelling considerations (discussed in the guideline's literature review and
Strength of
analyses) may also warrant a strong recommendation.
Recommendation
Moderate There is moderate confidence that the recommendation reflects best practice. This
is based on (1) good evidence for a true net effect (e.g., benefits exceed harms);
(2) consistent results, with minor and/or few exceptions; (3) minor and/or few
concerns about study quality; and/or (4) the extent of Expert Panelists'
agreement. Other compelling considerations (discussed in the guideline's
literature review and analyses) may also warrant a moderate recommendation.
Weak There is some confidence that the recommendation offers the best current
guidance for practice. This is based on (1) limited evidence for a true net effect
(e.g., benefits exceed harms); (2) consistent results, but with important
exceptions; (3) concerns about study quality; and/or (4) the extent of Expert
Panelists' agreement. Other considerations (discussed in the guideline's literature
review and analyses) may also warrant a weak recommendation.
Cost Analysis
The guideline developers reviewed published cost analyses.
Refer to "Cost Implications" for an analysis of economic impact.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
Members of the Expert Panel were responsible for reviewing and approving the penultimate version of the
guideline, which was then circulated for external review and submitted to Journal of Clinical Oncology for
editorial review and consideration for publication. All American Society of Clinical Oncology (ASCO)
guidelines are ultimately reviewed and approved by the Expert Panel and the ASCO Clinical Practice
Guideline Committee before publication. The Clinical Practice Guidelines Committee approved the
guideline on August 15, 2016.
External Review and Public Comment
The draft recommendations were released to the public for open comment from July 6 to 20, 2016. A total
of 94% of the 28 respondents either agreed or agreed with slight modifications to the recommendations,
whereas 6% of the respondents disagreed. Comments received were reviewed by the Expert Panel and
integrated into the final draft before approval by the ASCO Clinical Practice Guideline Committee.
Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see the "Major
Recommendations" field).
Benefits/Harms of Implementing the Guideline
Recommendations
Potential Benefits
There is now robust evidence from multiple large clinical trials that early palliative care improves
quality of life (QOL), reduces depression, and improves satisfaction with care. Early palliative care
also reduced the use of chemotherapy near end-of-life (EOL) for patients with lung cancer and
increased enrollment and length of stay in hospice, while improving survival. In a quasiexperimental
study in patients with lung cancer, benefits were noted primarily for patients with stage I to IIIB
disease rather than stage IV disease.
Early palliative care involvement may benefit family caregivers emotionally and psychologically by
lowering levels of depression, stress, caregiver burden, and psychological distress.
Refer to the "Literature review update and analysis" and "Clinical interpretation" sections of the original
guideline document for a discussion of the potential benefits of each recommendation.
Potential Harms
It is noteworthy that there were no adverse outcomes reported from early palliative care involvement in
any of the trials.
Refer to the "Literature review update and analysis" and "Clinical interpretation" sections of the original
guideline document for a discussion of the potential harms of each recommendation.
Qualifying Statements
Qualifying Statements
The clinical practice guidelines and other guidance published herein are provided by the American
Society of Clinical Oncology, Inc. (ASCO) to assist providers in clinical decision making. The
information herein should not be relied upon as being complete or accurate, nor should it be
considered as inclusive of all proper treatments or methods of care or as a statement of the
standard of care. With the rapid development of scientific knowledge, new evidence may emerge
between the time information is developed and when it is published or read. The information is not
continually updated and may not reflect the most recent evidence. The information addresses only
the topics specifically identified herein and is not applicable to other interventions, diseases, or
stages of disease. This information does not mandate any particular course of medical care. Further,
the information is not intended to substitute for the independent professional judgment of the
treating provider, because the information does not account for individual variation among patients.
Recommendations reflect high, moderate, or low confidence that the recommendation reflects the
net effect of a given course of action. The use of words like "must," "must not," "should," and
"should not" indicates that a course of action is recommended or not recommended for either most or
many patients, but there is latitude for the treating physician to select other courses of action in
individual cases. In all cases, the selected course of action should be considered by the treating
provider in the context of treating the individual patient. Use of the information is voluntary. ASCO
provides this information on an "as is" basis and makes no warranty, express or implied, regarding
the information. ASCO specifically disclaims any warranties of merchantability or fitness for a
particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or
property arising out of or related to any use of this information or for any errors or omissions.
Refer to the "Health Disparities," "Multiple Chronic Conditions," "Limitations of the Research" and
"Limitations of the Literature and Future Directions" sections in the original guideline document for
additional qualifying information.
This guideline uses the National Consensus Project definition of palliative care: "Palliative care
means patient and family-centered care that optimizes quality of life by anticipating, preventing, and
treating suffering. Palliative care throughout the continuum of illness involves addressing physical,